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Imaging Inflammation in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02831283
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2016
Last Update Posted : September 19, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
James M Noble, MD, MS, CPH, FAAN, Columbia University

Tracking Information
First Submitted Date  ICMJE July 10, 2016
First Posted Date  ICMJE July 13, 2016
Last Update Posted Date September 19, 2022
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
11C-PBR28 binding (standardized uptake value ratio) [ Time Frame: Up to 1 year from screening ]
In vivo quantification radioligand binding to TSPO expression on microglia in the brain.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2016)
11C-PBR28 binding (standardized uptake value ratio) [ Time Frame: Up to 1 year from screening ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
  • 18F-Florbetaben binding (standardized uptake value ratio) [ Time Frame: Up to 1 year from screening ]
    In vivo quantification of radioligand binding to Amyloid-Beta protein in the brain.
  • Cerebral spinal fluid (CSF) biomarkers [ Time Frame: Up to 1 year from screening ]
    Protein analysis of cerebral spinal fluid.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2016)
  • 18F-Florbetaben binding (standardized uptake value ratio) [ Time Frame: Up to 1 year from screening ]
  • Cerebral spinal fluid (CSF) biomarkers [ Time Frame: Up to 1 year from screening ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging Inflammation in Alzheimer's Disease
Official Title  ICMJE Imaging Inflammation in Elders With Different Clinical and Biomarker Profiles of Alzheimer's Disease
Brief Summary This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and do tests to measure the participants' memory and thinking.
Detailed Description This study is being done to determine the relationship between inflammation, cognitive impairment, and amyloid burden in elderly subjects with different clinical and biomarker profiles of Alzheimer's disease (AD). Participants will undergo amyloid PET imaging with 18F-Florbetaben with target number of completers being 15 amyloid-positive elders with impairment, 15 amyloid-positive elders with normal cognition, 15 amyloid-negative elders with impairment, and 15 amyloid-negative elders with normal cognition. Subjects will undergo screen that includes neuropsychological testing, brain MRI, and PET imaging with 18F-florbetaben to define the above 4 groups. Subjects will have 11C-PBR28 PET imaging to measure the 18 kDa translocator protein (a marker of inflammation). Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of amyloid,tau, phospho-tau, and inflammatory markers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: 11C-PBR28
    11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.
    Other Name: 11C-[O-methyl-11C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine
  • Drug: 18F-Florbetaben
    18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.
    Other Name: Neuraceq
  • Procedure: Lumbar puncture (optional)
    Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
    Other Name: LP
Study Arms  ICMJE
  • Experimental: Cognitive impairment
    Alzheimer's disease, Preclinical Alzheimer's disease or Impairment due to suspected non-Alzheimer's disease pathophysiology
    Interventions:
    • Drug: 11C-PBR28
    • Drug: 18F-Florbetaben
    • Procedure: Lumbar puncture (optional)
  • Active Comparator: No cognitive impairment
    Normal aging
    Interventions:
    • Drug: 11C-PBR28
    • Drug: 18F-Florbetaben
    • Procedure: Lumbar puncture (optional)
Publications * Klein J, Yan X, Johnson A, Tomljanovic Z, Zou J, Polly K, Honig LS, Brickman AM, Stern Y, Devanand DP, Lee S, Kreisl WC. Olfactory Impairment Is Related to Tau Pathology and Neuroinflammation in Alzheimer's Disease. J Alzheimers Dis. 2021;80(3):1051-1065. doi: 10.3233/JAD-201149.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 10, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 60 and older.
  2. Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
  3. Subjects unable to provide informed consent must have a surrogate decision maker
  4. Written and oral fluency in English or Spanish.
  5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
  6. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion Criteria:

  1. Past or present history of certain brain disorders other than MCI or AD.
  2. Certain significant medical conditions, which make study procedures of the current study unsafe.
  3. Contraindication to MRI scanning.
  4. Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.).
  5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
  6. Low affinity binding on TSPO genetic screen.
  7. Participation in the last year in a clinical trial for a disease modifying drug for AD.
  8. Inability to have a catheter in subject's vein for the injection of radioligand.
  9. Inability to have blood drawn from subject's veins.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02831283
Other Study ID Numbers  ICMJE AAAO1151
1K23AG052633-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party James M Noble, MD, MS, CPH, FAAN, Columbia University
Original Responsible Party William Charles Kreisl, Columbia University, Boris and Rose Katz Assistant Professor of Neurology (in the Taub Institute)
Current Study Sponsor  ICMJE James M Noble, MD, MS, CPH, FAAN
Original Study Sponsor  ICMJE William Charles Kreisl
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: James M. Noble, MD, MS Columbia University
PRS Account Columbia University
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP